Regard™

FDA UDI

Class I (US FDA UDI)

by Resource Optimization & Innovation, L.l.c.

Identity

Trade Name: Regard™ FDA UDI
Generic Name: Electrode/transducer strap, reusable FDA UDI
Device Name: Maternity Button Hole Fetal Belt, Iniv Size FDA UDI
Model / Reference: BTNBLT-REG FDA UDI
Description: Maternity Button Hole Fetal Belt, Iniv Size FDA UDI

Identifiers

Catalog Number: BTNBLT-REG FDA UDI
Primary DI / UDI-DI: 10326053118514 FDA UDI
FDA Product Code: ISR FDA UDI
GMDN Term: Electrode/transducer strap, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.3025 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Electrode/transducer strap, reusable

Regard™ by Resource Optimization & Innovation, L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrode/transducer strap, reusable.

BRAEBON 1-Foot Double Buckle Effort Belt — Braebon Medical Corp. · Class II
Clevemed — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD · Class II
Neurovirtual — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD · Class II
TONE-A-MATIC — Tone-A-Matic International, Inc. · Class II
Clevemed — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD · Class II
Neurovirtual — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD · Class II
Grass — S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
Sleepsense — S.L.P. INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Resource Optimization & Innovation, L.l.c.

Sources (1)

FDA UDI e1389ec0-7ad7-4f64-8262-edc06c57f080 34 fields · synced May 30, 2026